Catalog Number

-

Brand Name

Easy@Home Wrist Blood Pressure Monitor

Version/Model Number

EBP-017

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K122482,K122482

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

1c8e61c7-887f-4365-b2f0-778c81f1d49e

Public Version Date

November 08, 2019

Public Version Number

4

DI Record Publish Date

August 01, 2016

Package DI Number

10850253007199

Quantity per Package

20

Contains DI Package

00850253007192

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-